Malta - English - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 100 mg - antineoplastic agents

Malta - English - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - imatinib mesilate - hard capsule - imatinib mesilate 400 mg - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 100 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it s indicated for the treatment of:
paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid; leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.
paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated; phase or blast crisis.;
adult patients with ph+ cml in blast crisis.;
adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;
adult patients with relapsed or refractory ph+ all as monotherapy;
adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived; growth factor receptor (pdgfr) gene re-arrangements.;
adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 400 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it is indicated for the treatment of:
paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid; leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;
paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated; phase or blast crisis;
adult patients with ph+ cml in blast crisis;
adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;
adult patients with relapsed or refractory ph+ all as monotherapy;
adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived; growth factor receptor (pdgfr) gene re-arrangements;
adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - imatinib mesilate 478 mg - eq. imatinib 400 mg - capsule, hard - 400 mg - imatinib mesilate 478 mg - imatinib

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: crospovidone; sodium stearylfumarate; gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvan

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 59.735 mg (equivalent: imatinib, qty 50 mg) - capsule, hard - excipient ingredients: sodium stearylfumarate; gelatin; sodium lauryl sulfate; titanium dioxide; purified water; iron oxide yellow; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvan

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 477.88 mg (equivalent: imatinib, qty 400 mg) - capsule, hard - excipient ingredients: purified water; titanium dioxide; sodium lauryl sulfate; gelatin; sodium stearylfumarate; crospovidone; iron oxide yellow; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvan

Malta - English - Medicines Authority

aqvida gmbh - imatinib - hard capsule - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

aqvida gmbh - imatinib - hard capsule - imatinib 200 mg - antineoplastic agents